Is it Feasible to Conduct a Randomised Controlled Trial (RCT) of the Transverse Abdominis Plane (TAP) Block Versus Anaesthetic Injections to the Wound Site for Patients Requiring Laparoscopic Cholecystectomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total number of number of patients adhering to follow-up
研究概览
简要总结
The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy).
The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy.
One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only.
In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself.
The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.
详细描述
Pain control after laparoscopic cholecystectomy can be achieved with the injection of local anaesthetic into the abdominal wall (TAP block) or into the surgical wounds. There is no reported literature comparing the two techniques with regard to early discharge rate, consumption of oral painkillers and return to daily activities in the week following surgery. In an era where day case surgery has become reality, there is a pressing need for strategies to optimize patients' pathways. In this context the postoperative pain control is a key point.
To compare the two techniques in a randomized trial, a large number of participants would be needed. Therefore the investigators would conduct a pilot study first, to evaluate if further research in the form of a larger study is likely to demonstrate the benefits of the TAP block during laparoscopic cholecystectomy.
During the developing of the research proposal, advice and comments had been given by the local Research and Development Department and the public.
Recruitment
Clinicians will identify potential participants in the surgical outpatient clinic. All patients who fulfil the entry criteria will be invited to take part in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients able/willing to give informed consent for participation in the study.
- •Male or female aged 18-60 years old.
排除标准
- •Patients having an open cholecystectomy (performed through the standard "rope" incision).
- •Patients intended to have laparoscopic cholecystectomy as an inpatient (staying overnight after surgery).
- •Patients initially scheduled to have day case surgery but eventually admitted to hospital due to surgical or anaesthetic concerns or social reasons.
- •Patients with contraindications in having injection of the local anaesthetic used in the study (i.e. history of side-effects, allergy).
- •Patients who cannot have one or more standard oral painkillers prescribed postoperatively.
- •Patients with history of chronic pain who are already on long term painkillers.
- •Patients unable/unwilling to give informed consent for participation in the study.
研究组 & 干预措施
TAP block
Patients receive the injection of local anaesthetic into the right abdominal wall (TAP block) together with the injection of local anaesthetic into the surgical wounds.
干预措施: TAP Block (Drug)
Control
Patients receive the injection of local anaesthetic into the surgical wounds only.
干预措施: Control (Drug)
结局指标
主要结局
Total number of number of patients adhering to follow-up
时间窗: 24 months
Ability to collect adequate data
Total number of questionnaire responses
时间窗: 24 months
Ability to follow-up participants
Total amount number of patients who give their consent to take part to the study
时间窗: 24 months
Overall ability to recruit participants
次要结局
- Standard deviation (SD) of questionnaire scores between the two study arms(24 months)
- Standard deviation (SD) of hospital stay between the two study arms(24 months)
- Standard deviation (SD) of costs (hospital stay and prescription of painkillers) between the two study arms(24 months)